Phase 1 Studies to Evaluate the Food Effect and Relative Bioavailability of Tablet and Capsule Formulations of Belumosudil in Healthy Adult Subjects.
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DOI: 10.1002/cpdd.1083
Abstract: Belumosudil is a selective Rho-associated coiled-coil containing protein kinase 2 inhibitor. A capsule formulation was used during early clinical development of belumosudil; it was later replaced by a tablet formulation, which mimicked the capsule's release… read more here.
Keywords: phase studies; food; relative bioavailability; belumosudil ... See more keywords
A Pooled Analysis From Phase 2b and 3 Studies in Japan of Istradefylline in Parkinson's Disease
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DOI: 10.1002/mds.28095
Abstract: Characterization of patient factors associated with istradefylline efficacy may facilitate personally optimized treatment. read more here.
Keywords: japan istradefylline; analysis phase; istradefylline parkinson; studies japan ... See more keywords
Phase 1/1b Studies of UCB0599, an Oral Inhibitor of α‐Synuclein Misfolding, Including a Randomized Study in Parkinson's Disease
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DOI: 10.1002/mds.29170
Abstract: Parkinson's disease (PD) and its progression are thought to be caused and driven by misfolding of α‐synuclein (ASYN). UCB0599 is an oral, small‐molecule inhibitor of ASYN misfolding, aimed at slowing disease progression. read more here.
Keywords: phase studies; disease; parkinson disease; inhibitor ... See more keywords
Safety, pharmacodynamic, and pharmacokinetic characterization of vericiguat: results from six phase I studies in healthy subjects
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DOI: 10.1007/s00228-020-03023-7
Abstract: Purpose To characterize the safety, pharmacodynamics, and pharmacokinetics (PK) of vericiguat in healthy males. Methods Six phase I studies were conducted in European, Chinese, and Japanese males. Subjects received oral vericiguat as a single dose… read more here.
Keywords: vericiguat tablets; safety pharmacodynamic; six phase; vericiguat ... See more keywords
Results from multinational phase 3 studies of ravulizumab (ALXN1210) versus eculizumab in adults with paroxysmal nocturnal hemoglobinuria: subgroup analysis of Japanese patients
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DOI: 10.1007/s12185-020-02934-6
Abstract: Ravulizumab demonstrated noninferior efficacy and comparable safety to eculizumab in two open-label, phase 3 studies in patients with paroxysmal nocturnal hemoglobinuria (PNH) who complement inhibitor-naive (Study 301) or were previously treated with eculizumab (Study 302).… read more here.
Keywords: ravulizumab; study; japanese patients; eculizumab ... See more keywords
Onapristone Extended Release: Safety Evaluation from Phase I–II Studies with an Emphasis on Hepatotoxicity
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DOI: 10.1007/s40264-020-00964-x
Abstract: Introduction Antiprogestins have demonstrated promising activity against breast and gynecological cancers, but liver-related safety concerns limited the advancement of this therapeutic class. Onapristone is a full progesterone receptor antagonist originally developed as an oral contraceptive… read more here.
Keywords: phase studies; safety; onapristone; extended release ... See more keywords
From clusters to condensed phase – FT IR studies of water
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DOI: 10.1016/j.molliq.2016.12.037
Abstract: Abstract Intermolecular hydrogen bonding, which is formed between water molecules in the condensed state, causes a variety of unique properties of liquid water. In this paper the results of experimental FT IR studies of water… read more here.
Keywords: clusters condensed; phase; water; studies water ... See more keywords
MO126CLINICAL AND BIOMARKER CHARACTERISTICS OF PATIENTS WITH C3G OR IC-MPGN ENROLLED IN TWO PHASE II STUDIES INVESTIGATING THE FACTOR D INHIBITOR DANICOPAN*
Sign Up to like & getrecommendations! Published in 2021 at "Nephrology Dialysis Transplantation"
DOI: 10.1093/ndt/gfab092.004
Abstract: C3 glomerulopathy (C3G) and immune complex membranoproliferative glomerulonephritis (IC-MPGN) are rare, progressive kidney diseases requiring a biopsy for definite diagnosis. Both C3G and IC-MPGN are attributed to complement dysregulation, with dysregulation of the alternative pathway… read more here.
Keywords: biomarker; c3g mpgn; factor inhibitor; characteristics patients ... See more keywords
Efficacy and safety of EMA401 in peripheral neuropathic pain: results of two randomised, double-blind, phase 2 studies in patients with postherpetic neuralgia and painful diabetic neuropathy.
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DOI: 10.1097/j.pain.0000000000002252
Abstract: ABSTRACT The analgesic efficacy and safety of two Phase 2b studies of EMA401 (a highly selective angiotensin II type 2 receptor antagonist), in patients with postherpetic neuralgia (PHN; EMPHENE) and painful diabetic neuropathy (EMPADINE) were… read more here.
Keywords: painful diabetic; efficacy safety; phase studies; patients postherpetic ... See more keywords
Dose escalations in phase I studies: Feasibility of interpreting blinded pharmacodynamic data
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DOI: 10.1111/bcp.15473
Abstract: During phase I study conduct, blinded data are reviewed to predict the safety of increasing the dose level. The aim of the present study was to describe the probability that effects are observed in blinded… read more here.
Keywords: phase studies; feasibility interpreting; studies feasibility; escalations phase ... See more keywords
Design and analysis of two-phase studies with multivariate longitudinal data.
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DOI: 10.1111/biom.13616
Abstract: Two-phase studies are crucial when outcome and covariate data are available in a first phase sample (e.g., a cohort study), but costs associated with retrospective ascertainment of a novel exposure limit the size of the… read more here.
Keywords: longitudinal data; phase studies; analysis; phase ... See more keywords